Understanding Clinical Trials Landscape for Oncology in India

Closing gaps in clinical trial accessibility is vital to ensure equitable opportunities for diverse populations to benefit from advancements in cancer treatment

0
102
About Author: Dr Kausik Maiti, MD, Executive Director, Medical Sciences at Parexel India. As the Global Head of Safety Medical Sciences, Dr Kausik Maiti spearheads a team of over 300 highly qualified professionals across India, the US, the EU, and China. He leads significant initiatives in partnership with business partners, supervises client accounts and business operations, and provides strategic direction in the field of global safety services leadership.

India grapples with a grave crisis in the form of cancer, standing as the second-largest contributor to cancer deaths in Asia. Projections estimate a staggering rise to 1.57 million cases by 2025, signalling the urgent need for a robust understanding of this growing health challenge. However, despite the severity of the situation, India faces a critical barrier – the absence of accurate and comprehensive cancer data.
Why does this matter?
The National Cancer Registry Program (NCRP), initiated in 1982, serves as a pivotal tool in collecting cancer data nationwide. While this is a good start to keep track of cancer patients, its coverage remains inadequate, extending to only around 16.4% of the population. Accurate data forms the cornerstone of effective cancer surveillance. It plays a pivotal role in tracking trends, identifying high-risk populations, and evaluating the effectiveness of prevention efforts. The consequences of the data gap extend to hindering research and innovation, essential components in the fight against cancer.
The United States witnessed a notable 27% drop in cancer deaths between 2001 and 2020, driven by advancements in treatments, early detection, and a reduction in smoking. However, India lacks similar benchmarks, making it challenging to identify the driving factors behind the increasing cancer cases, understand remission rates, and assess the frequency of disease recurrence.
What does this mean for clinical trials and research?
Despite these challenges, there is a glimmer of hope in the form of ongoing clinical research. A recent Lancet report identified nearly 1,988 cancer trials were conducted between 2007 and 2021 in India, offering promise for testing new treatments and expanding our understanding of the disease. However, even within this positive research landscape, disparities emerge that warrant attention and intervention.
“Between 2007 and 2017, India conducted only 350 interventional cancer trials, a significant contrast to the 2066 trials registered in the US in 2017 alone. This stark difference underscores the urgency for India to accelerate and expand its research efforts in cancer.”
The majority of these trials (63%) focus primarily on treatment, emphasizing the urgent need for new therapeutic options. While this aligns with addressing common cancers prevalent in the country, certain critical areas such as surgery optimization (19%), toxicity mitigation (10.6%), and symptom management (7.6%) are neglected. Solid tumours dominate the trial landscape, with head neck, and cervical cancers. However, the North-Eastern states, burdened with a high incidence of cancer, face limited availability of clinical trials, posing challenges for patients in these regions to access potentially life-saving interventions.
Interpretation for Clinical Trials in Cancer
The Clinical Trials Registry—India (CTRI), launched in 2007, aims to bridge some of these gaps. A detailed examination of its data reveals concerning disparities when compared to the United States. Between 2007 and 2017, India conducted only 350 interventional cancer trials, a significant contrast to the 2066 trials registered in the US in 2017 alone. This stark difference underscores the urgency for India to accelerate and expand its research efforts in cancer.
Moreover, geographical disparities persist, with limited access to therapeutic trials even in states with the highest availability. The accessibility gap is further exaggerated by disparities between academic and industry-sponsored trials, posing challenges for certain patient populations to participate in clinical research. India’s favourable clinical trial eco-system (advancing medical infrastructure, English speaking qualified investigators, diverse patient population, and rigorous adherence to international regulatory and ethical standards) provides an excellent opportunity to conduct more and more interventional clinical trials in this country. Closing these gaps in clinical trial accessibility is vital to ensure equitable opportunities for diverse populations to benefit from advancements in cancer treatment.
By bridging the essential data gaps, India can empower research endeavours, tailoring interventions, and ultimately save lives. It is a call to action – an opportunity to transform the landscape of cancer care, ensuring that every individual, irrespective of their location or background, has access to the best possible cancer treatments and outcomes. Let us not allow this crisis to persist any longer – let’s act now for a healthier tomorrow.

*This story was first featured in the March-April 2024 edition of BioVoice eMagazine.